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Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
Date:6/3/2008

ip replacement surgeries. These trials are among those intended to support a broad Adlea label indication for the management of acute pain following orthopedic surgery.

How Adlea May Address the Need for Long-Duration, Well-Tolerated Pain Relief

Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of action results in site-specific efficacy intended to avoid the unwanted side effects associated with systemically administered analgesic drugs such as opioids and NSAIDs.

Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts primarily on TRPV-1 receptors residing on C-fiber neurons which transmit long-term pain by binding to and desensitizing these pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of 1 to 2 hours, and is undetectable in the blood after 24 hours.

Adlea's short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain, as well as pain due to moderate to severe osteoarthritis. In clinical trials to date, adverse events have been similar in patients receiving Adlea or placebo.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel pharmaceutical products for pain management. Anesiva has one FDA-approved product, Zingo(TM), for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. In clinical trials, the most common adverse reactions to Zingo were redness (erythema), red dots (petechiae) and swelling (edema). The next product in Anesiva's pipeline, Adlea(TM), is currently in two pivotal Phase 3 clini
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SOURCE Anesiva, Inc.
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Related medicine technology :

1. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
2. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
3. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
4. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
5. Anesiva Defines Regulatory Pathway for Adlea with FDA
6. Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery
7. Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery
8. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
9. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
10. Trubion Announces Presentation of Positive TRU-016 Data at ASCO
11. Alliance Pharmaceutical Corp. Announces Approval of Proposed Actions at Annual Shareholders Meeting

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